Lynne Ensor, PhD
Vice President, Regulatory Consulting Services Head of Global Compliance
Dr. Lynne Ensor is the Vice President, RCS Head of Global Compliance, for Parexel International and has been a consultant to the biopharmaceutical industry since 2019. Her areas of expertise include sterile product manufacturing and testing, pharmaceutical microbiology, facility compliance, and regulatory strategy. Prior to consulting, Lynne was employed by the U.S. Food and Drug Administration (FDA) for 21 years. While at FDA, she served as the Deputy Director (Acting) in the Office of Process and Facilities (OPF)/Office of Pharmaceutical Quality/Center for Drug Evaluation and Research and was responsible for new, generic, biologic and biosimilar drug product quality (CMC) review and facility assessment. Her previous FDA management positions include serving as the Director of the OPF’s Division of Microbiology Assessment, Director of the Office of Pharmaceutical Sciences’ New and Generic Drug Product Quality Microbiology staff, and Director of Office of Generic Drugs’ Division of Microbiology. Lynne’s previous experience includes serving as a Clinical Microbiologist at Roche Biomedical Laboratories, a script consultant for the Discovery Channel, and a Post-doctoral Fellow at the University of Maryland at Baltimore’s School of Medicine. She earned her B.S. in Biology and Ph.D. in Microbiology from the University of Maryland, College Park.